Government green-lights faster approval of COVID-19 medical equipment

The federal government is temporarily allowing equipment that is needed to combat the COVID-19 pandemic to bypass the usual approval process needed for medical devices being imported or sold in Canada.

Health Minister Patty Hajdu’s interim order from almost two weeks ago was made official in the issue of the Canada Gazette published on Friday. The Canada Gazette is the government’s publication of record, used to keep track of new laws and regulations and announce when they come into effect.

Hajdu now has the power to use “discretion in the level of evidence” to determine the safety and effectiveness of medical devices used to treat COVID-19 patients or others suspected of having the illness. In the case of COVID-19, devices could include equipment like test kits and ventilators. Hajdu can also deem that devices usually used to treat other diseases can be used to treat COVID-19. The government is keeping a list online of equipment being newly used to treat coronavirus, but it’s currently empty.

“The objective of the proposal is to mitigate and prevent infections caused by (the new coronavirus) and to protect the health and safety of Canadians in relation to COVID-19 by providing timelier access to medical devices used in the diagnosis, treatment, mitigation, or prevention of COVID-19,” says part of a note explaining the interim order.

As the federal minister of health, Hajdu has the ability under the federal Food and Drugs Act to make temporary changes to which type of medical devices are allowed in Canada and how they’re permitted if she believes there’s an immediate risk posed to public health. Her order clears hurdles for buyers for up to one year.

To sell medical devices, equipment providers still have to follow some of the typical requirements, including providing basic details about the device and its operation, and information about its reliability and effectiveness. Certain operational requirements still remain to ensure the imported equipment is being used properly and isn’t harming patients in any unforeseen way.

Since the number of COVID-19 cases began escalating in Canada, there have been questions about whether the country has the capability to maintain an adequate supply of medical equipment throughout the pandemic. In Ontario, Canada’s most populous province and the jurisdiction in the country reporting the second-most COVID-19 cases (with 1,706 on Monday), front-line health-care workers already temporarily ran short on testing kitsand have been worried about rationing personal protective equipment (which has also been expedited), as well as eventually running out of ventilators, which in patients with severe symptoms of COVID-19 can be crucial in keeping them alive.

After saying about a week and a half ago that there were 5,000 ventilators in Canada, deputy chief public health Dr. Howard Njoo said on Sunday that the federal government is undertaking another count with the provinces and territories to determine how many they now have available.

“It’s difficult to say what number of ventilators is needed because as I stated earlier, what we’re planning to do is actually prepare the system so that we will never have to have that peak, sort of, requirement for a certain number of ventilators at one time,” Njoo said.

The federal government has been encouraging provinces and territories to work with it to procure equipment, like ventilators, collectively.

It’s also transforming existing funding programs to compel domestic manufacturers to either increase their production capacity for medical equipment or to re-tool their facilities to produce what’s necessary for health care workers and patients in the pandemic. The Canadian business community has responded in a willing way publicly, with a spokesperson for the Canadian Chamber of Commerce (CCC) telling iPolitics last week that it will continue working with the federal government improve the procurement process and connect it with businesses to ensure the most important equipment is readily available. According to its website, the CCC represents more than 450 chambers of commerce and boards of trade, which themselves speak for 200,000 businesses, from small to large in size.

More than 220,000 people in Canada had been tested for COVID-19 by Monday. There were 6,317 confirmed cases in the country by midday and 66 people had died from the illness by that time.

The epicentre of the outbreak – in terms of where the most reported cases have been – is Canada’s neighbour, the United States. On Monday, there were close to 150,000 Americans, including people in every state, who had tested positive for COVID-19. More than 2,500 people in the U.S. have died as a result of the coronavirus. President Donald Trump suggested on Sunday that keeping deaths in the country under 100,000 would be an optimistic total.

The World Health Organization reported on Sunday that by then there were more than 630,000 reported cases of COVID-19 worldwide, and almost 30,000 people had died from the disease.